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This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.

Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.

Patients' quality of life is assessed by the FACT-O, the FACT-Ntx subscale, the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.

Percent of women, who are 70 years or older, able to complete at least 4 cycles of treatment regardless of dose reduction and delays [ Time Frame: Up to 5 years ]

While this percentage will be estimated for each study regimen separately, the targeted sample size will limit the width of the 95%-confidence interval for the marginal percentage so that it is no larger than 0.15.

Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days [ Time Frame: Up to 5 years ]

Will be modeled with logistic regression using baseline IADL scores as a covariate. Exploratory analysis will evaluate baseline IADL scores adjusting for covariates such as: Charlson scale, nutritional status, or age.

Secondary Outcome Measures
:

Changes in comorbidity index measured by the Charlson scale [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]

Changes in nutritional status measured by weight [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]

The changes in weight will be summarized descriptively as the differences of scores between pre and post chemotherapy. The change of nutritional status after completing chemotherapy will be examined using McNemar's test.

Changes in quality-of-life measured by FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ]

The changes in FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL will be summarized descriptively as the differences of scores between pre and post chemotherapy. Assuming 80% of patients complete the assessment at the completion of chemotherapy, then a sample of 148 patients will provide 90% power to detect 5 unit changes in FACT-O, 0.5 unit change in FACT/GOG-Ntx subscale score, 1 unit change in IADL or ADL score using paired t-test at significant level of 0.05.

Clinical response of elderly patients with ovarian, primary peritoneal cavity, or fallopian tube cancer [ Time Frame: Up to 5 years ]

Percent of patients reporting adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events [ Time Frame: Up to 6 weeks after course 4 ]

The probability of an adverse event will be estimated as the percent of patients reporting an adverse event out of all patients beginning treatment.

The observed pharmacokinetics of paclitaxel and carboplatin will be compared with published pharmacokinetic measures of paclitaxel and carboplatin in a descriptive fashion. No formal statistical testing will be performed for the comparisons.

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Ages Eligible for Study:

75 Years and older (Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Criteria

Inclusion Criteria:

Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only

International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible

Patients must have received no previous treatment for this malignancy other than surgery

Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery

Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

Platelets greater than or equal to 100,000/mcl

Bilirubin less than or equal upper limit of normal (ULN)

Creatinine less than or equal to 1.5 x ULN

Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3

Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013)

Patients must have recovered from the effects of recent surgery

Patients must be free of active infection requiring antibiotics

Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA)

Patient and physician agree that they plan to conduct treatment according to Regimen 3

Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments

Exclusion Criteria:

Patients who have received previous treatment for this malignancy other than surgery